ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transpl… (NCT07247097) | Clinical Trial Compass
Not Yet RecruitingPhase 2
ELDORADO: Elranatamab Versus Daratumumab in Combination With RVd Lite for Newly Diagnosed Transplant Ineligible/Deferred Multiple Myeloma
United States160 participantsStarted 2026-04-15
Plain-language summary
This research study is being done to compare the efficacy and safety of the combination of elranatamab, lenalidomide, bortezomib, dexamethasone versus the combination of daratumumab, lenalidomide, bortezomib, dexamethasone for patients with newly diagnosed, transplant ineligible/deferred multiple myeloma.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Serum monoclonal protein ≥0.5 g/dL. For IgA monoclonal protein, total IgA \>500 mg/dL is allowable.
✓. Urine monoclonal protein ≥200 mg/24 hours
✓. Involved serum free light chain ≥100 mg/L with abnormal free light chain ratio
✓. Have 2 negative pregnancy tests as verified by the Investigator prior to starting study therapy within 10-14 days, with the second test within 24 hours of starting lenalidomide. She must agree to ongoing pregnancy testing during the course of the study, and after end of study treatment. This applies even if the subject practices true abstinence from heterosexual contact.
✓. Either commit to true abstinence from heterosexual contact (which must be reviewed on a monthly basis and source documented) or agree to use and be able to comply with two reliable forms of contraception as defined by lenalidomide Risk Evaluation and Mitigation Strategy (REMS) program.
Exclusion criteria
✕. Basal or squamous cell carcinoma of the skin
✕. Carcinoma in situ of the cervix
✕. Ductal carcinoma in situ of the breast
✕. Incidental histologic finding of prostate cancer (T1a or T1b) managed with surveillance
✕. Other malignancies of clinically localized disease may be permitted to enroll after discussion with the Sponsor-Investigator
✕. Congestive heart failure (New York Heart Association \[NYHA\] Class 3 or 4)
What they're measuring
1
Proportion Patients who test Negative for Minimal Residual Disease (MRD) at 10^-5 after 4 Treatment Cycles
Timeframe: Day 1 of Cycle 1 (each cycle is 28 days) to Day 28 of Cycle 4.